This paper reports on the baseline stage of a qualitative evaluation of the application of the Innovative Scorecard (ISC) to the Clinical and Translational Science Award (CTSA) at the University of Texas Medical Branch (UTMB) at Galveston. The ISC is adopted from the established Balanced Scorecard system for strategic planning and performance management. In formulating the evaluation, we focused on the organizational identity literature.

The initial evaluation consisted of a series of semi-structured interviews with 22 participants of the ISC Boot Camp conducted in July 2015.

The logic of grounded theory pointed to the clustering of perceptions of the ISC around respondents’ occupational locations at UTMB. Administrators anticipate the expansion of planning activities to include a wider range of participants under the current CTSA award period (2015–2020) than under our first CTSA approval period (2009–2014). A common viewpoint among the senior scientists was that the scientific value of their work will continue to speak for itself without requiring the language of business. Junior scientists looked forward to the ISC’s emphasis on increasingly horizontal leadership that will give them more access to and more control over their work and resources. Postdocs and senior staff welcomed increased involvement in the total research process at UTMB.

The report concludes with strategies for future follow-up.

Engaging patients, caregivers, and other stakeholders to help guide the research process is a cornerstone of patient-centered research. Lived expertise may help ensure the relevance of research questions, promote practices that are satisfactory to research participants, improve transparency, and assist with disseminating findings.

Traditionally engagement has been conducted face-to-face in the local communities in which research operates. Decentralized platform trials pose new challenges for the practice of engagement. We used a remote model for stakeholder engagement, relying on Zoom meetings and blog communications.

Here we describe the approach used for research partnership with patients, caregivers, and clinicians in the planning and oversight of the ACTIV-6 trial and the impact of this work. We also present suggestions for future remote engagement.

The ACTIV-6 experience may inform proposed strategies for future engagement in decentralized trials.

Computational analysis of genome or exome sequences may improve inherited disease diagnosis, but is costly and time-consuming.

We describe the use of iobio, a web-based tool suite for intuitive, real-time genome diagnostic analyses.

We used iobio to identify the disease-causing variant in a patient with early infantile epileptic encephalopathy with prior nondiagnostic genetic testing.

Iobio tools can be used by clinicians to rapidly identify disease-causing variants from genomic patient sequencing data.

Studies examining the role of geographic factors in coronavirus disease-2019 (COVID-19) epidemiology among rural populations are lacking.

Our study is a population-based longitudinal study based on rural residents in four southeast Minnesota counties from March through October 2020. We used a kernel density estimation approach to identify hotspots for COVID-19 cases. Temporal trends of cases and testing were examined by generating a series of hotspot maps during the study period. Household/individual-level socioeconomic status (SES) was measured using the HOUSES index and examined for association between identified hotspots and SES.

During the study period, 24,243 of 90,975 residents (26.6%) were tested for COVID-19 at least once; 1498 (6.2%) of these tested positive. Compared to other rural residents, hotspot residents were overall younger (median age: 40.5 vs 43.2), more likely to be minorities (10.7% vs 9.7%), and of higher SES (lowest HOUSES [SES] quadrant: 14.6% vs 18.7%). Hotspots accounted for 30.1% of cases (14.5% of population) for rural cities and 60.8% of cases (27.1% of population) for townships. Lower SES and minority households were primarily affected early in the pandemic and higher SES and non-minority households affected later.

In rural areas of these four counties in Minnesota, geographic factors (hotspots) play a significant role in the overall burden of COVID-19 with associated racial/ethnic and SES disparities, of which pattern differed by the timing of the pandemic (earlier in pandemic vs later). The study results could more precisely guide community outreach efforts (e.g., public health education, testing/tracing, and vaccine roll out) to those residing in hotspots.

The field of dissemination and implementation science has the potential to narrow the translational research-to-practice gap and improve the use of evidence-based practices (EBPs) within community-based settings. Yet, foundational research related to dissemination efforts, such as understanding researcher attitudes, practices, and the determinants to sharing research findings, is lacking within extant literature.

A sequential explanatory (QUAN $$ \to $$ qual) mixed methods design was used to examine 85 academic researchers’ perspectives and self-reported dissemination methods used to share research outcomes with community stakeholders to better understand researcher’s usual dissemination practices (referred to as dissemination-as-usual). Quantitative surveys collected researcher demographic data, attitudes toward dissemination efforts, and dissemination strategy use.

Multiple linear regression examined predictors of the quantity of dissemination strategies utilized by researchers, finding that years since earning their degree, time spent disseminating, and the number of reasons for engaging in dissemination efforts predicted greater numbers of dissemination strategies utilized by researchers. Individual, semi-structured interviews with a subset of researchers (n = 18) expanded upon quantitative findings, identifying barriers and facilitators to their dissemination efforts. Data strands were integrated using a joint display, and the Dissemination of Research model guided data interpretation. More established researchers experienced fewer barriers and more facilitators to support their use of a variety of dissemination strategies to share findings with community stakeholders. However, researchers reported needing specific training, institutional support, and/or dedicated time to plan and enact dissemination strategies.

The necessary first step in research translation is the dissemination of research evidence, and understanding dissemination-as-usual can identify areas of need to advance translational science.

The electronic health record (EHR) and patient portal are used increasingly for clinical research, including patient portal recruitment messaging (PPRM). Use of PPRM has grown rapidly; however, best practices are still developing. In this study, we examined the use of PPRM at our institution and conducted qualitative interviews among study teams and patients to understand experiences and preferences for PPRM.

We identified study teams that sent PPRMs and patients that received PPRMs in a 60-day period. We characterized these studies and patients, in addition to the patients’ interactions with the PPRMs (e.g., viewed, responded). From these groups, we recruited study team members and patients for semi-structured interviews. A pragmatic qualitative inquiry framework was used by interviewers. Interviews were audio-recorded and analyzed using a rapid qualitative analysis exploratory approach.

Across ten studies, 35,037 PPRMs were sent, 33% were viewed, and 17% were responded to. Interaction rates varied across demographic groups. Six study team members completed interviews and described PPRM as an efficient and helpful recruitment method. Twenty-eight patients completed interviews. They were supportive of receiving PPRMs, particularly when the PPRM was relevant to their health. Patients indicated that providing more information in the PPRM would be helpful, in addition to options to set personalized preferences.

PPRM is an efficient recruitment method for study teams and is acceptable to patients. Engagement with PPRMs varies across demographic groups, which should be considered during recruitment planning. Additional research is needed to evaluate and implement recommended changes by study teams and patients.

Little is known about practices used to disseminate findings to non-research, practitioner audiences. This study describes the perspectives, experience and activities of dissemination & implementation (D&I) scientists around disseminating their research findings.

The study explored D&I scientists’ experiences and recommendations for assessment of dissemination activities to non-research audiences. Existing list serves were used to recruit scientists. Respondents were asked three open-ended questions on an Internet survey about dissemination activities, recommendations for changing evaluation systems and suggestions to improve their own dissemination of their work.

Surveys were completed by 159 scientists reporting some training, funding and/or publication history in D&I. Three themes emerged across each of the three open-ended questions. Question 1 on evaluation generated the themes of: 1a) promotional review; 1b) funding requirements and 1c) lack of acknowledgement of dissemination activities. Question 2 on recommended changes generated the themes of: 2a) dissemination as a requirement of the academic promotion process; 2b) requirement of dissemination plan and 2c) dissemination metrics. Question 3 on personal changes to improve dissemination generated the themes of: 3a) allocation of resources for dissemination activities; 3b) emerging dissemination channels and 3c) identify and address issues of priority for stakeholders.

Our findings revealed different types of issues D&I scientists encounter when disseminating findings to clinical, public health or policy audiences and their suggestions to improve the process. Future research should consider key requirements which determine academic promotion and grant funding as an opportunity to expand dissemination efforts.

Community stakeholders often participate in community research training curricula development. There is limited information describing how their input informs curricula. This paper describes input solicitation methods, input received, and examples of its integration.

From June 2014 to June 2016, community members (CMs) and community-based organizations (CBOs) guided curricula development tailored for CMs and CBOs, respectively. Engagement methods included a strategic planning retreat, surveys, a listening session, workgroup meetings, and community engagement studios. Descriptive statistics were used to summarize survey input. For other methods, input was extracted and compiled from facilitator notes.

CMs (n=37) and CBOs (n=83) providing input included patients and caregivers and advocacy, community service, and faith-based organizations, respectively. The major feedback categories were training topic priorities, format (e.g., face-to-face vs. online), logistics (e.g., training frequency), and compensation (e.g., appropriateness). Input directly guided design of CBO and CM curricula (e.g., additional time devoted to specific topics based on feedback) or helped to finalize logistics.

Multiple quantitative and qualitative methods can be used to elicit input from community stakeholders to inform the development of community research training curricula. This input is essential for the development of training curricula that are culturally relevant and acceptable.

The Institute of Translational Health Sciences (ITHS) promotes and supports translational research collaboration between clinicians, communities, and investigators across the five-state Washington, Wyoming, Alaska, Montana, and Idaho (WWAMI) region. The ITHS has developed a collaborative regional clinical research network, the Northwest Participant & Clinical Interactions Network (NW PCI), involving 12 diverse clinical health systems and academic institutions.

This descriptive article details NW PCI’s development, infrastructure and governance, tools, characteristics, and initial outcomes.

Regional NW PCI sites are conducting largely industry-sponsored studies; they are interested in including more grant-funded research. Regional NW PCI sites had over 1,240 open studies involving over 6700 patients in 2016. NW PCI trials are largely industry-sponsored; NW PCI sites are interested in including more grant-funded research. In its first three years, the NW PCI Coordinating Center facilitated regional sites’ participation in 34 new grant and contract applications across diverse topics.

The NW PCI model supports the goals of the developing CTSA Trial Innovation Network by increasing access to cutting-edge research across the Northwestern U.S., by supporting investigators seeking diverse populations, including those with rare diseases, for their research studies, and by providing settings to test implementation and dissemination of effective interventions.

The National Academies of Sciences (NAS) emphasize the need for interdisciplinary team science (TS) training, but few training resources are available. COALESCE, an open-access tool developed with National Institutes of Health support and located at teamscience.net, is considered a gold standard resource but has not previously been evaluated. COALESCE launched four learning modules in 2011. The Science of TS (SciTS) module, an interactive encyclopedia, introduces foundational concepts. Three scenario-based modules simulate TS challenges in behavioral, clinical, and basic biomedical sciences. This study examined user characteristics, usage patterns, and effects of completing the four modules on TS knowledge, attitudes, and skills.

Repeated measures ANOVA tested for pre-post changes in performance and compared learning by users with biomedical versus other disciplinary backgrounds.

From 2011 through 2017, the site attracted 16,280 new users who engaged in 6461 sessions that lasted more than 1 min. The modal registrant identified as working in a biomedical field (47%), in an academic institution (72%), and expressed greater interest in the practice than the SciTS (67%). Those completing pre- and post-tests (n = 989) showed significant improvement in knowledge, attitudes, and skills after taking all scenario-based modules (p < 0.005); knowledge and attitudes were unchanged after the SciTS encyclopedia. Biomedical and other health professionals improved comparably.

Evaluation of the TS training tool at teamscience.net indicates broad dissemination and positive TS-related outcomes. Site upgrades implemented between 2018 and 2020, including adding five new modules, are expected to increase the robustness and accessibility of the COALESCE training resource.

Health systems have many incentives to screen patients for health-related social needs (HRSNs) due to growing evidence that social determinants of health impact outcomes and a new regulatory context that requires health equity measures. This study describes the experience of one large urban health system in scaling HRSN screening by implementing improvement strategies over five years, from 2018 to 2023.

In 2018, the health system adapted a 10-item HRSN screening tool from a widely used, validated instrument. Implementation strategies aimed to foster screening were retrospectively reviewed and categorized according to the Expert Recommendations for Implementing Change (ERIC) study. Statistical process control methods were utilized to determine whether implementation strategies contributed to improvements in HRSN screening activities.

There were 280,757 HRSN screens administered across 311 clinical teams in the health system between April 2018 and March 2023. Implementation strategies linked to increased screening included integrating screening within an online patient portal (ERIC strategy: involve patients/consumers and family members), expansion to discrete clinical teams (ERIC strategy: change service sites), providing data feedback loops (ERIC strategy: facilitate relay of clinical data to providers), and deploying Community Health Workers to address HRSNs (ERIC strategy: create new clinical teams).

Implementation strategies designed to promote efficiency, foster universal screening, link patients to resources, and provide clinical teams with an easy-to-integrate tool appear to have the greatest impact on HRSN screening uptake. Sustained increases in screening demonstrate the cumulative effects of implementation strategies and the health system’s commitment toward universal screening.

The National Institute of Health has mandated good clinical practice (GCP) training for all clinical research investigators and professionals. We developed a GCP game using the Kaizen-Education platform. The GCP Kaizen game was designed to help clinical research professionals immerse themselves into applying International Conference on Harmonization GCP (R2) guidelines in the clinical research setting through case-based questions.

Students were invited to participate in the GCP Kaizen game as part of their 100% online academic Masters during the Spring 2019 semester. The structure of the game consisted of 75 original multiple choice and 25 repeated questions stemming from fictitious vignettes that were distributed across 10 weeks. Each question presented a teachable rationale after the answers were submitted. At the end of the game, a satisfaction survey was issued to collect player satisfaction data on the game platform, content, experience as well as perceptions of GCP learning and future GCP concept application.

There were 71 total players who participated and answered at least one question. Of those, 53 (75%) answered all 100 questions. The game had a high Cronbach’s alpha, and item analyses provided information on question quality, thus assisting us in future quality edits before re-testing and wider dissemination.

The GCP Kaizen game provides an alternative method for mandated GCP training using principles of gamification. It proved to be a reliable and an effective educational method with high player satisfaction.

Clinical Research Coordinators (CRCs) are key members of research teams who ensure rigorous conduction of clinical studies and quality standard compliance. Yet, their roles and responsibilities are still not well defined, and formal recognition of their professional profile is lacking in Italy. This survey of Italian healthcare institutions collected data on centers’ research activities number of CRCs and tasks they performed and explored factors associated with CRC employment.

Cross-sectional study using a brief questionnaire. Data were analyzed by means of graphical representations, histogram, scatter, and polar plots. Multivariable linear regression was specified to test the association between the number of CRCs and a subset of factors.

Data collection took place from February to December 2020. 62/143 institutions (43.4%) responded. Median number of ongoing studies reported by centers was 65 (IQR 29–205); of these, median of sponsored and interventional studies was 32 and 35, respectively. Median number of CRCs employed at each center was 6 (IQR 2–9). The frequency with which activities were reported to be performed by CRCs overlapped with those of Data Managers. Linear multivariable regression analysis revealed a statistically significant association between the number of employed CRCs and the number of sponsored studies (P = 0.01), but not with the total number of studies, geographical location, or institution type.

The association between industry funding and the number of CRCs observed in this study should be further explored to understand the direction of this relationship and to verify whether this may influence compliance with quality standards.